Poliovirus Trial for Pediatric Brain Tumors Funded
On Wednesday, Sept. 28, Matthias Gromeier, MD; Eric Thompson, MD; and Darell Bigner, MD, PhD; received a check for $208,408 from The Andrew McDonough B+ Foundation (The B+ Foundation) and Solving Kids’ Cancer (SKC) in honor of Steph Bader, a 13-year-old-girl who passed away from glioblastoma. The funds will help launch a new immunotherapy trial for children battling deadly brain tumors.
Bigner, director of The Preston Robert Tisch Brain Tumor Center, is considered one of the leading authorities on brain tumors in the world. Thompson is a pediatric neurosurgeon who specializes in the treatment of brain tumors, spinal cord tumors and skull and spine tumors.
Gromeier, professor in the departments of Neurosurgery, Molecular Genetics and Microbiology, and Medicine at Duke University School of Medicine and his lab developed the recombinant poliovirus therapy, an immunotherapy to battle brain cancer. His work has received a wealth of attention from the oncology research community and was featured on CBS’s” 60 Minutes twice (March 2015 and May 2016).
The U.S. Food and Drug Administration granted “breakthrough therapy designation status” in May to prioritize research into the engineered oncolytic poliovirus (PVS-RIPO), citing evidence that Gromeier’s ongoing phase 1 study for adults appears to show increased survival rates among some early study participants with grade 4 malignant gliomas. These brain tumors are otherwise terminal upon diagnosis.
“PVS-RIPO may stimulate an immune response that can recognize tumor-associated antigens and that can selectively kill tumor cells,” said Gromeier. “We have seen dramatic responses in some of the adult trial participants who have universally fatal recurrent glioblastoma. We look forward to expanding our study to test this approach in pediatrics.”
“I feel confident my child in heaven is smiling down on us and is pleased with what we are accomplishing here today,” said Joe McDonough, Founder and President, The Andrew McDonough B+ Foundation, shaking Gromeier’s hand, then Bigner’s.
McDonough’s foundation honors the life of his son Andrew who battled leukemia, septic shock and complications of childhood cancer for 167 days before passing away on July 14, 2007, at the age of 14.
Enrollment in a phase 1 clinical trial of the oncolytic poliovirus therapy for eligible children with recurrent high-grade brain tumors is expected to open by the end of 2016 at The Preston Robert Tisch Brain Tumor Center at Duke Cancer Institute.
The trial is expected to enroll 10-15 children and the PVS-RIPO poliovirus will be delivered directly to the tumor by convection-enhanced delivery (CED), just as it is in the adult trial. CED is an emerging technology that delivers agents directly to the tumor in the brain using a small, surgically inserted catheter.
“If our involvement can help just an inch along the way, then our efforts here today are well worth the investment,” said Scott Kennedy, cofounder and Executive Director, Solving Kids’ Cancer, a non-profit that focuses on aggressive childhood cancers with low survival rates and helps accelerate new, next-generation treatments, including immunotherapy, cancer vaccines, and new drugs.